GRP-035 Boceprevir and Telaprevir: Safety

Abstract

Background Protease inhibitors boceprevir and telaprevir were approved by the European Medicines Agency in July and September 2011 respectively
for the treatment of hepatitis C genotype-1 in combination with peginterferon and ribavirin (triple therapy).

Purpose To describe the safety of boceprevir and telaprevir in clinical practise.

Materials and Methods All patients who received triple therapy prior to commercialization (compassionate use) with boceprevir or telaprevir to
September 2012 were included. Data collected were: drugs administered for triple therapy, analytical parameters (haemoglobin,
neutrophils and platelets) and subjective adverse effects. Patients were educated by the pharmacist about the medicines at
the start of triple therapy and interviewed about adverse effects monthly with each refill of triple therapy.

Results Of the 36 patients with chronic hepatitis C included, 16 were treated with telaprevir and 20 with boceprevir. The most frequent
adverse reactions were anaemia, neutropenia and thrombocytopenia. Anaemia was managed by reducing the dose of ribavirin (7
patients), erythropoiesis-stimulating agents (11 patients) and packed cells (7 patients). Neutropenia and thrombocytopenia
were controlled with peginterferon dose reduction (2 patients) and granulocyte colony-stimulating factor (4 patients). Other
adverse effects were fatigue or discomfort (16 patients), insomnia (5 patients), fever (5 patients), pruritus, dysgeusia,
headache, nausea, diarrhoea and irritability. Eight patients had to discontinue treatment due to adverse reactions which were
not controlled with dose adjustment or supportive drugs.

Conclusions All adverse events observed were reported in the EMA studies. Protease inhibitors have shown improve sustained virological
response in clinical trials but these drugs are associated with a lot of adverse reactions. It is very important to have close
collaboration between the physician and the pharmacist for medicines management, so that adverse reactions not described in
the drug information will be reported to health agencies.